This invention relates to the use of a unique oral preparation for the treatment of inflammatory skin conditions. More particularly, this invention relates to a composition and method for the treatment of inflammatory skin conditions such as acne rosacea and acne vulgaris comprising an immediate release form of nicotinamide in combination with a sustained release form of zinc combined complementary other active ingredients to provide optimum levels of several different treatment modalities. The combination of an immediate release nicotinamide and sustained release zinc provides an unexpected synergistic anti-inflammatory effect that is not observed with combinations of immediate release forms of both chemicals.
Acne vulgaris is an inflammatory disease of the pilosebaceous glands characterized by an eruption of the skin, often pustular in nature but not suppurative. Acne is a common affliction of the adolescent and affects a small but significant percentage of the adult population. Acne lesions are of four basic types: comedones (blackheads or whiteheads), papules, pustules, and cysts (or nodules). Various topical agents are utilized in the treatment of acne and these include sulfur, resorcinol, salicylic acid, benzoyl peroxide, vitamin A acid and topical antibiotics. Other treatment methods include topically applying various scrubbing or abrasive compositions, topically applying deep cleaning or astringent compositions, and also exposure to ultraviolet radiation. Acne involvement can result in unsightly lesions, particularly on the face, and in some cases in severe scarring.
Acne rosacea is another inflammatory skin affliction characterized by erythema with or without an acneiform component (papules, pustules, or nodules). Rosacea typically occurs in adults of about 30–50 years of age. The acneiform component or rosacea has been treated in the past in a fashion similar to the treatment for acne vulgaris. Systemic antibiotics have also been helpful.
Nicotinamide and nicotinic acid are water soluble vitamins whose physiologically active forms include nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP). Nicotinamide and nicotinic acid have been used routinely to treat pellegra for which they are therapeutic. Nicotinamide is available from a variety of pharmaceutical houses such as Roche Vitamin, Inc., of Nutley, N.J.; Armor Pharmaceutical Company located in Phoenix Ariz.; Brown Pharmaceutical Company Inc. located in Los Angeles, Calif.; and Keith Pharmaceutical Inc. located in Miami, Fla.
It is known that a high dose of immediate release nicotinamide will have greater bioavailability and greater extended activity than that of a sustained release application.
U.S. Pat. No. 4,505,896 teaches the use of oral compositions containing nicotinamide in the treatment of acne vulgaris. The nicotinamide is administered orally in doses of 100–600 milligrams per day in divided doses taken 2 to 4 times per day. The treatment was reported to decrease inflammatory lesions such as papules, pustules, and cysts, but not comedones.
U.S. Pat. No. 4,725,609 teaches the topical application of nicotinamide to promote angiogenesis, reepithelialization and wound healing.
U.S. Pat. No. 5,459,153 teaches a method for treatment of acne vulgaris comprising administration to a patient of a mixture of pantothenic acid, nicotinic acid, and biotin, to generate nicotinamide in vivo.
U.S. Pat. No. 5,989,523 teaches a topical spray of 1–10% niacinamide with a humectant to treat acne.
U.S. Pat. No. 6,020,351 teaches selectively administering a daily dosage of carotenoids, nicotinamide, and a source of zinc, in excess of normal dietary levels for improving resistance to DNA damage, enhancing DNA repair capacity, and stimulating immune function.
U.S. Pat. No. 6,248,763 teaches the topical application of nicotinamide to treat acne.
It has been reported in the medical literature that acne is often associated with low zinc levels in blood serum and in the epidermal layer. The therapeutic effect of zinc as an anti-inflammatory agent has been well documented, and oral zinc has been reported to be helpful in the treatment of certain types of acne. It is also known that zinc supplementation should be used with copper supplementation to avoid a copper deficiency that might otherwise occur.